Compositions for treatment of psoriasis of the scalp

ABSTRACT

Described herein are compositions for topical administration, to relieve psoriasis of the scalp. The compositions comprise a cannabinoid and at least one additional active ingredient. The additional active ingredient may be salicylic acid or coal tar. The compositions may be biphasic compositions comprising an aqueous phase and an oil-based phase. The two phases may be contained in a single container and mixed, for example, by shaking, before administration of the composition to the scalp of the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

Benefit is claimed to U.S. Provisional Patent Application 63/029,627filed May 25, 2020; the contents of which is incorporated by referenceherein in its entirety.

FIELD

Provided herein are topical compositions for treatment of scalppsoriasis.

BACKGROUND

Psoriasis of the scalp is a skin disorder associated with any of thefollowing symptoms: dry scalp, scaly patches on the scalp, hair loss,burning, soreness and white scales. Psoriasis of the scalp may cover afew spots or large areas of the scalp, extending from the forehead tothe back of the neck and around the ears. Scalp psoriasis may bedifficult to treat. Psoriasis of the scalp may be treated withintralesional steroids injected to the affected areas, but suchtreatment is typically used in small areas of the scalp. In addition,steroid use is often associated with side effects.

SUMMARY

Described herein are compositions for topical administration, to relievepsoriasis of the scalp. The compositions comprise a cannabinoid and atleast one additional active ingredient. The additional active ingredientmay be salicylic acid or coal tar. The compositions may be biphasiccompositions comprising an aqueous phase and an oil-based phase. The twophases may be contained in a single container and mixed, for example, byshaking, before administration of the composition to the scalp of thepatient.

Additionally described herein are methods for treating psoriasis of thescalp comprising administering to a person in need thereof a compositioncomprising a pharmaceutically effective amount of a cannabinoid and ofat least one additional active ingredient.

The foregoing and other objects, features, and advantages will becomemore apparent from the following detailed description.

DETAILED DESCRIPTION

Unless otherwise noted, technical terms are used according toconventional usage. Definitions of common terms in pharmaceuticalsciences can be found in Troy et al. Remington: The Science and Practiceof Pharmacy. Published by Lippincott Williams & Wilkins, 2006. In caseof conflict, the present specification, including explanations of terms,will control. In addition, all the materials, methods, and examples areillustrative and not intended to be limiting.

Unless otherwise explained, all technical and scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which this disclosure belongs. The singular terms“a,” “an,” and “the” include plural referents unless context clearlyindicates otherwise. Similarly, the word “or” is intended to include“and” unless the context clearly indicates otherwise. It is further tobe understood that all base sizes or amino acid sizes, and all molecularweight or molecular mass values, given for nucleic acids or polypeptidesare approximate, and are provided for description. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of this disclosure, suitable methods andmaterials are described below. The term “comprises” means “includes.”The abbreviation, “e.g.” is derived from the Latin exempli gratia and isused herein to indicate a non-limiting example. Thus, the abbreviation“e.g.” is synonymous with the term “for example.”

Definitions:

Allantoin: (2,5-Dioxo-4-imidazolidinyl) urea.

Cannabinoid: A cannabinoid is a chemical compound that acts oncannabinoid receptors in cells in mammals, including in humans.Cannabinoids can be manufactured synthetically or obtained from variousparts of the genus Cannabis, in particular, from the species CannabisSativa. Cannabinoids from the cannabis plant are referred to asphytocannabinoids. Two preferred cannabinoids according to variousembodiments, are (−)-trans-Δ⁹-tetrahydrocannabinol, and/or isomersthereof (THC) and cannabidiol (CBD). Alternatively, a cannabinoid may bein the form of cannabis extract. Alternatively, a cannabinoid may be inthe form of a synthetic cannabinoid. Compositions described herein maycomprise one cannabinoid or multiple cannabinoids, such as a combinationof CBD and THC.

Salicylic Acid: 2-hydroxybenzoic acid.

Zinc-PCA: Proline, 5-oxo-, zinc salt. Zinc pidolate.

Description of Embodiments

Topical compositions for treating psoriasis of the scalp arecommercially available in “wash off” form, which is intended to bewashed out within minutes of application, and in “leave on” form, whichis intended to be applied and left on the scalp for many hours. Ingeneral, compositions which are formulated for leaving on the scalp aretypically more effective than “wash off” compositions in treatingpsoriasis of the scalp. However, if “leave on” compositions are left onthe scalp for long periods of time, they may cause irritation of thescalp. Some “leave on” compositions comprise alcohol, which has beenfound to cause dryness of the skin and irritation, which may beespecially problematic in patients suffering from psoriasis.

Some compositions for treating psoriasis which are intended to be lefton the scalp comprise significant amounts of oil-based solvent. Suchcompositions, when applied to the scalp, may provide an unaesthetic,oily appearance to the hair. as a result, treatment may be limited tonighttime, before sleep.

Described herein, according to some embodiments, are compositions whichare intended to be left on the scalp or to be washed off, comprising acannabinoid and at least one additional active ingredient. Thecompositions comprise biphasic mixtures, having an aqueous phase and anoil-based phase, which are packaged together in the same receptacle, butexist primarily as two separate phases. When the composition is shaken,the phases combine, as determined by visual examination, and can then beapplied to an affected area of a patient suffering from psoriasis of thescalp. It is suggested that such compositions will be advantageousrelative to currently available compositions by providing effectivetreatment without providing an unaesthetic appearance and withoutcausing irritation to the scalp.

Compositions according to embodiments described herein may comprise acannabinoid or a plurality of cannabinoids selected from the groupconsisting of CBD and THC. Optionally, the cannabinoid is CBD. Thecannabinoid may be present in an amount of between 0.001 and 10%,preferably 0.1 and 2 percent, by weight, of the compositions.Optionally, the cannabinoid is present in an amount of 0.25% by weight.

According to an embodiment, the additional active ingredient issalicylic acid. The salicylic acid may be present in the composition inan amount between 1.8% and 3.0% by weight. Optionally, the salicylicacid is present in the composition in an amount of 2.0%.

According to an embodiment, the additional active ingredient is coaltar. Optionally, the coal tar is present in the composition in an amountof 0.5-5% by weight.

According to an embodiment, the composition comprises hemp oil in theoil phase of the composition. Optionally, hemp oil is present in thecomposition in an amount of between 0.5% and 5% of the composition.Optionally, hemp oil is present in an amount of 1% of the composition.

According to an embodiment, the composition has less than 1% alcohol byweight. According to an embodiment, the composition is free of C1-C4alcohol. For example, the composition is free of ethanol andisopropanol.

Optionally the composition is free of a steroid.

According to an embodiment the ratio, by weight of aqueous tonon-aqueous phase to oil-based phase is between 60:40 to 90:10.

According to an embodiment, the composition comprises less than 5% byweight of emulsifier, optionally, the composition is free of emulsifier.

According to an embodiment, the composition comprises a solubilizer. Thesolubilizer may be polysorbate-20.

According to an embodiment, the composition comprises at least oneadditional ingredient selected from the group consisting of: menthol,tea tree oil, Zinc-PCA, allantoin, and olive oil.

According to an embodiment, the composition comprises at least oneadditional active agent selected from the group consisting ofmethotrexate, cyclosporine, hydroxycarbamide, fumaric acid esters, aretinoid, efalizumab and alefacept, vitamin D and derivatives thereof,calcipotriene, betamethasone, halobetasol and Metaderm®. Metaderm ® is aplant based lotion or cream which comprises the following plantextracts: achillea millefolium, aesculus hippocastanum, berberisvulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra,rhus toxicodendron, and sanguinaria canadensis. Optionally, the fumaricacid ester comprises dimethylfumarate. Optionally, the retinoid istazarotene or acitretin.

Optionally, the menthol is present in the composition in an amountbetween 0.1-1%, preferably 0.2%.

Optionally, the tea tree oil is present in the composition in an amountbetween 0.1-1%, preferably 0.3%.

Optionally, the Zinc-PCA is present in the composition in an amountbetween 0.05-0.5%, preferably 0.1%.

Optionally, the allantoin is present in the composition in an amountbetween 0.1-1%, preferably 0.5%.

Optionally, the olive oil is present in the composition in an amountbetween 0.5-5%, preferably 1%.

The viscosity of the composition is preferably in the range of between0.5 and 200 centipoise (cps) at 25° C. Preferably, the determination ofviscosity is performed immediately after shaking.

According to an embodiment, the composition may be in the form of aliquid, provided in a bottle for spraying onto an affected area. Thebottle may have a flip cap and be used to apply directly to the scalp.Alternatively, the bottle may be a hair-root applicator bottle equippedwith a comb at the bottle opening to allow the bottle opening to beadjacent to the scalp when applying. The bottle may be equipped with adropper to allow easy application to the scalp. Optionally, thecomposition may be in an aerosol spray or a pump spray. The pump spraymay be a bottle equipped with a button spray or a trigger spray. Thecompositions may be packaged in a packaging and provided withinstructions to shake before use.

In addition to active ingredients, compositions described herein mayfurther comprise at least one inert ingredient. The inert ingredient maybe selected from the group consisting of: water, a solvent, anemollient, a moisturizer, a pH adjustment agent, a polymer, a humectant,an occlusive agent, a preservative, a thickener, an anti-irritationagent, a conditioning agent, a buffer, a vitamin, an extract, a naturaloil, a wax, a penetration enhancer, a peptide, a sugar derivative, afatty acid, a fatty alcohol, a silicone, a polyethyl-glycol, afragrance, a pigment, an ester, a triglyceride, an antioxidant and anabsorbing powder.

According to an embodiment, the composition comprises an aqueous phaseand an oil-based, non-aqueous phase. The biphasic composition may beshaken or stirred by the user before administration. Optionally, thenon-aqueous phase comprises the cannabinoid. Optionally, upon shakingthe composition, both phases mix and do not separate for at least 10seconds, preferably at least 30 seconds, most preferably at least 2minutes.

It is suggested that a biphasic composition may provide stability to thecomposition in that the water-soluble active ingredient is contained inan aqueous environment and the cannabinoid is contained in a non-aqueousenvironment. Biphasic compositions, when stored, are separated into twophases. Before use, the patient is instructed to shake the container inwhich the composition is stored and from which the composition isdispensed for a number of seconds between 2 and 5 times. The phases ofthe biphasic composition then combine, as determined by visualinspection, and the composition can be applied, preferably by spraying,onto the scalp of the patient in need.

Phase separation optionally happens in greater than 30 seconds from theshaking of the biphasic composition. Phase separation preferably happensbetween 30 sections from the shaking of the biphasic composition until10 minutes from the shaking of the biphasic composition. Mostpreferably, phase separation happens between 1 minute from shaking ofthe biphasic composition until 3 minutes from shaking the biphasiccomposition.

According to an embodiment, the cannabinoid is dissolved in an oil.Optionally, the oil may be hemp oil, olive oil, or an essential oil.Optionally, the oil is an ester, a triglyceride, a hydrocarbon, a fattyalcohol, mineral oil, silicon oil, ethoxylate alcohol, or vegetable oil.

According to an embodiment, the pH of the composition after shaking isbetween 3 and 4. Optionally, the pH is 3.2. Optionally, the pH electrodeis calibrated at pH of 4 and pH of 7, then immediately immersed in thecomposition after shaking.

Additional embodiments of the composition relate to a pharmaceuticalcomposition for topical administration comprising a cannabinoid and anadditional active ingredient selected from the group consisting of:tazarotene, calcipotriene, betamethasone, halobetasol and Metaderm®.

Additional embodiments relate to methods for treatment of a condition ofthe scalp comprising administering to a patient in need thereof, apharmaceutical composition via the topical route comprising acannabinoid and an additional active ingredient selected from the groupconsisting of salicylic acid and coal tar. The condition of the scalp isselected from the group consisting of: psoriasis of the scalp, dandruff,and seborrheic dermatitis. The composition may comprise two phases, anaqueous and an oil-based phase.

Treatment of psoriasis of the scalp may involve treatment of symptoms ofpsoriasis including one or more than one of the following symptoms:thickened, dry, scaly, flaky, cracked, itchy, red and or inflamed skin.

Treatment of dandruff may involve treatment of symptoms of dandruff,including one or more than one of the following symptoms: flaking anditching of the scalp.

According to an embodiment, the composition may be applied daily,optionally, between 1 and 4 times daily. Optionally, the composition isapplied and left on the patient's scalp.

According to an embodiment, the composition may be applied in an amountof between about 0.05 milliliter (ml) and about 1 ml per spray (per pumprelease). Optionally, the composition may be applied in an amountbetween 0.1 ml and 0.25 ml per spray. The composition may be applied viaa single spray burst or multiple spray bursts to cover an affected area.

The following examples are provided to illustrate certain particularfeatures and/or embodiments. These examples should not be construed tolimit the disclosure to the particular features or embodimentsdescribed.

EXAMPLES Example 1

A spray for treatment of psoriasis of the scalp was prepared using theingredients described in table 1:

TABLE 1 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Zinc-PCA Anti-inflammatory 0.10 Propylene glycolCarrier and humectant 2.0 Menthol Active agent 0.20 OctyldodecanolEmollient & solvent 15.0 Olive Oil Emollient 1.0 Salicylic Acid Activeagent 2.0 BHT Antioxidant 0.05 Sativa seed (Hemp) oil Solvent 1.0Cannabidiol Active agent 0.25 Tea tree oil Essential oil antifungal 0.3agent Polysorbate-20 Solubilizer 2.0 Sodium Hydroxide pH adjusting agent0.3

In a main vessel, water, disodium EDTA, allantoin and zinc-PCA wereadded and mixed until completely dissolved. In a separate vessel,menthol and propylene glycol were dissolved, then added to the mainvessel while mixing. In a separate vessel, octyldodecanol, olive oil,salicylic acid, BHT, hemp oil, cannabidiol and tea tree oil were addedand mixed to form the oil-based phase. The oil-based ingredients werecombined with polysorbate-10 (Tween ®-20) and were then added to themain vessel. The pH was checked and adjusted with NaOH to between 3 and4. The product was then introduced into pump-bottles.

The viscosity of the composition was analyzed and found to be less than200 cps.

The composition prepared is advantageous in that it comprises an aqueouslayer and an oil-based layer. The cannabinoid remains stable while inthe oil-based layer. Upon mixing by shaking, the biphasic mixture ismixed to form a single phase for 2 minutes and 45 seconds, allowing apatient in need to apply the composition having a cannabinoid andanother active ingredient, conveniently, to the affected area. Afteradministration, much of the water-phase of the composition evaporatesand does not leave an oily residue on a patient's hair and scalp. Afteradministration, the aqueous and oil-based layers separate, providingadditional stability to the composition.

Example 2

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 2.

TABLE 2 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Symsoft ® Scalp Soothing of itching 1.00(Trideceth-9, PEG-5- scalp Ethylhexanoate, Water, HydroxyphenylPropamidobenzoic Acid) Propylene glycol Carrier and humectant 3.0Menthol Active agent 0.20 Octyldodecanol Emollient & solvent 15.0 OliveOil Emollient 1.0 Salicylic Acid Active Agent 2.0 BHT Antioxidant 0.05Sativa seed (Hemp) oil Solvent 1.0 Cannabidiol Active agent 0.25 Teatree oil Essential oil antifungal 0.3 agent Polysorbate-20 Solubilizer2.0

Symsoft® Scalp is an clear, light colored liquid made by Symrise andavailable at www. Symrise.com.

Example 3

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 3.

TABLE 3 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Zinc-PCA Anti-inflammatory 0.10 PropanediolHumectant 2.0 Menthol Active agent 0.20 Octyldodecanol Emollient &solvent 15.0 Olive Oil Emollient 1.0 Salicylic Acid Active agent 2.0 BHTAntioxidant 0.05 Sativa seed (Hemp) oil Solvent 1.0 Cannabidiol Activeagent 0.25 Leptospermum Scoparium Essential oil antifungal 0.1Branch/Leaf Oil agent Caprylyl/Capryl Glucoside Solubilizer 1.0

Example 4

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 4.

TABLE 4 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Aloe Vera gel Soothing agent 2.0 Symsoft Scalp(Trideceth-9, Soothing of itching 1.0 PEG-5-Ethylhexanoate, scalp Water,Hydroxyphenyl Propamidobenzoic Acid) Propylene glycol Carrier andhumectant 3.0 Menthol Active agent 0.10 Octyldodecanol Emollient &solvent 15.0 Avocado Oil Emollient 1.0 Salicylic Acid Active agent 2.0BHT Antioxidant 0.05 Sativa seed (Hemp) oil Solvent 1.0 BisabololSoothing agent 0.10 Cannabidiol Active agent 0.25 Tea tree oil Essentialoil antifungal 0.3 agent

Example 5

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 5.

TABLE 5 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Aloe Vera gel Soothing agent 2.0 Symsoft Scalp(Trideceth-9, Soothing of itching 1.0 PEG-5-Ethylhexanoate, scalp Water,Hydroxyphenyl Propamidobenzoic Acid) Propylene glycol Carrier andhumectant 3.0 Menthol Cooling agent 0.10 Octyldodecanol Emollient &solvent 15.0 Avocado Oil Emollient 1.0 Salicylic Acid Active agent 2.0BHT Antioxidant 0.05 Sativa seed (Hemp) oil Solvent 1.0 Tumeric oilAnti-inflammatory 0.10 Cannabidiol Active agent 0.25 Tea tree oilEssential oil antifungal 0.3 agent Caprylyl/Capryl Glucoside Solubilizer1.0

Example 6

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 6.

TABLE 6 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Aloe Vera gel Soothing agent 1.0 Zinc-PCAAnti-inflammatory 0.10 Propylene glycol Carrier and humectant 2.0Menthol Cooling agent 0.20 Octyldodecanol Emollient & solvent 15.0 OliveOil Emollient 1.0 Salicylic Acid Active Agent 2.0 BHT Antioxidant 0.05Bisabolol Soothing Agent 0.1 Sativa seed (Hemp) oil Solvent 1.0Cannabidiol Active Agent 0.25 Tea tree oil Essential oil antifungal 0.3agent Polysorbate-20 Solubilizer 1.0 Sodium Hydroxide pH adjustingagent, to 0.4 pH of 3.5

Example 7

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 7.

TABLE 7 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Aloe Vera gel Soothing agent 1.0 Zinc-PCAAnti-inflammatory 0.10 Propylene glycol Carrier and humectant 2.0Menthol Active agent 0.20 Octyldodecanol Emollient & solvent 20.0 OliveOil Emollient 1.0 Salicylic Acid Active agent 3.0 BHT Antioxidant 0.05Bisabolol Soothing agent 0.1 Sativa seed (Hemp) oil Solvent 1.0Cannabidiol Active agent 0.25 Tea tree oil Essential oil antifungal 0.3agent Polysorbate-20 Solubilizer 1.0 Sodium Hydroxide pH adjustingagent, to 0.4 pH of 3.5

Example 8

A spray for treatment of psoriasis of the scalp is prepared using asimilar process as in Example 1, using the ingredients in Table 8:

TABLE 8 Amount Ingredient Function (percent by weight) Water Aqueousphase solvent Up to 100 Disodium EDTA Chelating agent 0.05 AllantoinSkin protectant 0.50 Propylene glycol Carrier and humectant 2.0 MentholActive agent 0.20 Octyldodecanol Emollient & solvent 15.0 Castor oilHair growth promoter 2.0 Olive Oil Emollient 1.0 Salicylic Acid ActiveAgent 3.0 BHT Antioxidant 0.05 Bisabolol Soothing agent 0.1 Sativa seed(Hemp) oil Solvent 1.0 Cannabidiol Active Agent 0.25 Coal Tar (SolutionActive Agent 1.3 comprising 84.3% Coal Tar in solvent)

Example 9 Suggested Treatment Method

A composition prepared according to any of the previous examples isapplied to affected areas one to four times daily or as directed by adoctor.

Before applying, the patient twists the flow-control cap to open. Ifusing after shampooing hair, the patient's hair is towel dried. Thecomposition may be applied from bottle directly to scalp, and massagedin. To avoid running or dripping, the patient should take care notsqueeze bottle too hard. the composition should be stored at 20-25° C.(68-77 degrees F.) and protected from humidity.

According to an embodiment, disclosed is a biphasic pharmaceuticalcomposition for treatment of psoriasis comprising an aqueous phase andan oil-based phase, wherein the composition comprises a cannabinoid andat least one additional agent selected from the group consisting ofsalicylic acid and coal tar. Optionally, the cannabinoid is selectedfrom the group consisting of full spectrum cannabis, CBD and THC.Optionally, the cannabinoid is CBD. Optionally, wherein the cannabinoidis present in an amount between 0.001% and 10% by weight of thecomposition. Optionally, the cannabinoid is present in an amount between0.1% and 1% by weight of the composition. Optionally, the cannabinoid ispresent in an amount of 0.25% by weight. Optionally, the additionalagent is salicylic acid. Optionally, the salicylic acid is present in anamount between 1.8% and 3% by weight of the composition. Optionally, theadditional agent is coal tar. Optionally, the coal tar is present in anamount between 0.5-5% by weight of the composition. Optionally, thecompositions has a viscosity of between 0.5 and 200 centipoise at 25° C.immediately after shaking. Optionally, the composition further comprisesat least one of the agents selected from the group consisting of:menthol, tea tree oil, Zinc-PCA, allantoin, olive oil, methotrexate,cyclosporine, hydroxycarbamide, fumaric acid esters, a retinoid,efalizumab and alefacept, vitamin D and derivatives thereof,calcipotriene, betamethasone, halobetasol and a mixture of the followingplant extracts: achillea millefolium, aesculus hippocastanum, berberisvulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra,rhus toxicodendron, and sanguinaria canadensis. Optionally, thecomposition is free of a C1-C4 alcohol. Optionally, the composition isfree of a steroid. Optionally, after shaking the composition by hand,the phases do not mix and separate only after between 30 seconds and 10minutes following shaking. Optionally, after shaking the composition byhand, the phases do not mix and separate only after between 2 and 3minutes following shaking. Optionally, the composition is for treatmentof psoriasis of the scalp.

Some embodiments relate to a method for treatment of a condition of thescalp selected from the group consisting of: psoriasis of the scalp,dandruff and seborrheic dermatitis comprising topically administering toa patient in need thereof, a composition comprising an aqueous phase andan oil-based phase, wherein the composition comprises a cannabinoid andat least one additional agent selected from the group consisting ofsalicylic acid and coal tar. Optionally, the cannabinoid is selectedfrom the group consisting of full spectrum cannabis, CBD and THC.Optionally, the cannabinoid is CBD. Optionally, the cannabinoid ispresent in an amount between 0.001% and 10% by weight of thecomposition. Optionally, the cannabinoid is present in an amount between0.1% and 1% by weight of the composition. Optionally, the cannabinoid ispresent in an amount of 0.25% by weight. Optionally, the additionalagent is salicylic acid. Optionally, the salicylic acid is present in anamount between 1.8% and 3% by weight of the composition. Optionally, theadditional agent is coal tar. Optionally, the coal tar is present in anamount between 0.5-5% by weight of the composition. Optionally, thecomposition has a viscosity of between 0.5 and 200 centipoise at 25° C.immediately after shaking. Optionally, the composition comprises atleast one of the agents selected from the group consisting of: menthol,tea tree oil, Zinc-PCA, allantoin, olive oil, methotrexate,cyclosporine, hydroxycarbamide, fumaric acid esters, a retinoid,efalizumab and alefacept, vitamin D and derivatives thereof,calcipotriene, betamethasone, halobetasol and a mixture of the followingplant extracts: achillea millefolium, aesculus hippocastanum, berberisvulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra,rhus toxicodendron, and sanguinaria canadensis. Optionally, thecomposition is free of a C1-C4 alcohol. Optionally, the composition isfree of a steroid. Optionally, after shaking the composition by hand,the phases do not mix and separate only after between 30 seconds and 10minutes following shaking Optionally, after shaking the composition byhand, the phases do not mix and separate only after between 2 and 3minutes following shaking. Optionally, the condition is psoriasis of thescalp. Optionally, the treatment is for symptoms of psoriasis includingone or more than one of the following symptoms: thickened, dry, scaly,flaky, cracked, itchy, red skin and inflamed skin. Optionally, thecomposition is administered by spray in an amount of between 0.05 ml and1 ml per spray. Optionally, the composition is administered between onceand 4 times daily. Optionally, the method further comprises shaking thecomposition before administering the composition topically. Optionally,the composition is administered to the scalp of a patient via a hairroot applicator bottle, a dropper, an aerosol spray or pump spray.Optionally, the method further comprises leaving the composition on thescalp for between 1 and 12 hours after application.

Further embodiments relate to packaged, sealed pharmaceuticalcomposition comprising: a composition as described above, containedwithin a sealed container, the container selected the group consistingof a bottle having a flip cap, a bottle having a root applicator, abottle having a dropper, an aerosol spray canister, a pump spraycanister.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

1. A biphasic pharmaceutical composition for treatment of psoriasiscomprising an aqueous phase and an oil-based phase, wherein thecomposition comprises a cannabinoid and at least one additional agentselected from the group consisting of salicylic acid and coal tar. 2.The composition according to claim 1 wherein the cannabinoid is selectedfrom the group consisting of full spectrum cannabis, CBD and THC.
 3. Thecomposition according to claim 2 wherein the cannabinoid is CBD.
 4. Thecomposition according to claim 1 wherein the cannabinoid is present inan amount between 0.001% and 10% by weight of the composition.
 5. Thecomposition according to claim 4 wherein the cannabinoid is present inan amount between 0.1% and 1% by weight of the composition.
 6. Thecomposition according to claim 5 wherein the cannabinoid is present inan amount of 0.25% by weight.
 7. The composition according to claim 1wherein the additional agent is salicylic acid.
 8. The compositionaccording claim 7 wherein the salicylic acid is present in an amountbetween 1.8% and 3% by weight of the composition.
 9. The compositionaccording to claim 1 wherein the additional agent is coal tar.
 10. Thecomposition according claim 9 wherein the coal tar is present in anamount between 0.5-5% by weight of the composition.
 11. The compositionaccording to claim 1 having a viscosity of between 0.5 and 200centipoise at 25° C. immediately after shaking.
 12. The compositionaccording to claim 1 comprising at least one of the agents selected fromthe group consisting of: menthol, tea tree oil, Zinc-PCA, allantoin,olive oil, methotrexate, cyclosporine, hydroxycarbamide, fumaric acidesters, a retinoid, efalizumab and alefacept, vitamin D and derivativesthereof, calcipotriene, betamethasone, halobetasol and a mixture of thefollowing plant extracts: achillea millefolium, aesculus hippocastanum,berberis vulgaris, conium maculatum, matricaria chamomilla, phytolaccadecandra, rhus toxicodendron, and sanguinaria canadensis.
 13. Thecomposition according to claim 1, and free of a C1-C4 alcohol.
 14. Thecomposition according to claim 1, and free of a steroid.
 15. Thecomposition according to claim 1 wherein after shaking the compositionby hand, the phases do not mix and separate only after between 30seconds and 10 minutes following shaking.
 16. The composition accordingto claim 15 wherein after shaking the composition by hand, the phases donot mix and separate only after between 2 and 3 minutes followingshaking.
 17. (canceled)
 18. A method for treatment of a condition of thescalp selected from the group consisting of: psoriasis of the scalp,dandruff and seborrheic dermatitis comprising topically administering toa patient in need thereof, a composition comprising an aqueous phase andan oil-based phase, wherein the composition comprises a cannabinoid andat least one additional agent selected from the group consisting ofsalicylic acid and coal tar. 19.-35. (canceled)
 36. The method accordingto claim 18 wherein the composition is administered by spray in anamount of between 0.05 ml and 1 ml per spray.
 37. The method accordingto claim 18 wherein the composition is administered between once and 4times daily.
 38. The method according to claim 18 further comprisingshaking the composition before administering the composition topically.39.-41. (canceled)